Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript

Mar 12, 2020 • 04:30 pm ET

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Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript

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Q & A
Executive
Taneli Jouhikainen

more carefully to see if there is some pattern that isn't obvious in the averages. And this is what we mean when we say that we'll be still evaluating the outcomes more and putting back together eventually with the ENCORE data as well.

Analyst
Josh Schimmer

And then, comment on exacerbations in the NTM study and per and the extent to which we may offset on the benefit.

Executive
Taneli Jouhikainen

So this would fall into the same category of patient anecdotes, so -- like it's very difficult in this type of a study to make a judgment as to like are we reducing exacerbation rates when we have in our control group. But that said, like I spoke about the other types of clinical outcomes, we will be looking into some cases, where perhaps regardless of the microbiology there might still be some suppression of infection and there could be some impact on exacerbation frequency. So that's definitely possible.

Analyst
Josh Schimmer

Got it. Thanks very much.

Executive
Rob Neville

Thank you.

Operator
Operator

[Operator Instructions] Our next question will come from Suji Jeong of Jefferies. Please go ahead.

Analyst
Suji Jeong

Hi. This is Suji. Thanks for taking my question. So I have a question about the AeroVanc Phase 3 trial. You said you're going to enroll about 140 patients for the primary analysis group instead of 150 originally planned. So I was wondering if they would impact the powering assumption.

Executive
Rob Neville

Well, obviously any adjustment of sample size downwards has some effect. In this case, it is a few percent point, so it is not a very big impact.

Analyst
Suji Jeong

Okay. And then, my second question is on the IMPALA, the second IMPALA study. Could you guys comment on the interactions with the EMA so far?

Executive
Badrul Chowdhury

On the second IMPALA study, our initial interaction will be with the FDA. And through that interaction, we would like to come up with a design that is agreeable with the FDA. And then, we will consider to discuss that with the EMA.

Analyst
Suji Jeong

Okay. That's good to know. And my last question is the number of deaths that you saw in the OPTIMA study. So I was just wondering if that 3 deaths that you saw, is that similar to -- is that what you would have expected, given the severity of the disease?

Executive
Badrul Chowdhury

Yeah. I mean, obviously, small study, so the numbers just reflect the severity. We have often old subjects who have chronic disease and advanced disease as well. So there is not much more to it.

Analyst
Suji Jeong

I see. All right. Great. Thank you.

Operator
Operator

Ladies and gentlemen, this will conclude our question-and-answer session. At this time, I'd like to turn the conference back over to Rob Neville for closing remarks.

Executive
Anne Erickson

And actually we got one question over e-mail, so I'll just read it out. Have you seen the coronavirus impacting your business at all? And if so, what are you doing about it?

Executive
Rob Neville

Thank you for that question. The exact impact of the outbreak obviously is a concern. We're doing all the necessary precautions from a company standpoint.